LFU:online

Students will know all regulations of the European (including EMA) and national authorities (including EU-Commission, European Council, EDQM, EMA, national agencies)

• The European Medicines Network  - EC, EMA, NCAs (National Competent Authorities), EDQM
• Role, responsibility and structure of the EMA and NCAs
• Committees of the EMA and European experts database
• Interaction between EMA and NCAs
• Transparency and disclosure of Information
• EU Telematics – network / system
• EDQM

Lecture with interactive elements involving student participation, audience response systems, online handouts

written exam

Modules 1 and 2